Congress tackles online drugstore debate

An increasingly contentious House subcommittee hearing opens the debate about who is monitoring the sale of prescription drugs over the Internet and what laws are being violated.

January 2, 20024:43 PM PST

An increasingly contentious House subcommittee hearing today opened the debate about who is monitoring the sale of prescription drugs over the Internet and what laws are being violated.

As earlier reported, in stunning morning testimony two TV journalists presented investigative reports of how a 7-year-old child, a dead man, and a neutered dog easily obtained drugs from online pharmacies. Their booty included an illegal substance, which violates federal law.

The subcommittee set out today to see who is accountable for overseeing this new phenomenon--but learned that maybe no one is. The responsibility should fall to states, but the problem is also federal because of interstate trade and drug laws.

On one side, e-commerce advocates say online pharmacies should be self-regulated. On the other, Internet drugstore critics demand strict monitoring and laws.

"It is probably not safe right now to be purchasing drugs from an online pharmacy that is not well known," Dr. Janet Woodcock, director of the Food and Drug Administration, told the Oversight and Investigations Subcommittee of the House Commerce Committee this afternoon.

Lawmakers argued that this statement refers to all Internet drugstores, not just lesser-known ones. "Who is protecting the American public?" asked Rep. Ron Klink (D-Pennsylvania).

After seeking assurance from federal regulators that they were policing online violations of controlled-substance laws, lawmakers didn't seem to get the answers they wanted. "We are left with more questions than answers," noted one representative.

Rep. Bart Stupak (D-Michigan) repeatedly asked Woodcock to cite some case or investigation that the FDA had undertaken to prosecute unlawful online practices, but she struggled to do so.

"Where's the cop on the beat, so to speak?" Stupak said.

The only example Woodcock could produce was a California case involving a bogus HIV test kit. But that, Stupak pointed out, is not a controlled substance. "I don't believe there have been investigations, just a lot of paper-pushing," he declared angrily. "... You go from 26 [online pharmacies] in January to over 400 in July--what are you doing [to address this]?

Subcommittee members returned to the issue of controlled substances again and again, introducing evidence of how easy it is to purchase illegal medications over the Internet.

Rep. Fred Upton (R-Michigan) produced a case in which an unnamed online drugstore automatically posts a disclaimer that the doctor issuing prescriptions is not licensed in the United States and is working from Mexico.

"This is as close to a signed confession as I've ever seen," Klink observed.

In this case, Upton told Woodcock there were "four obvious illegal acts," including practicing medicine without a license. The FDA director agreed and said she would investigate, but would not promise the kind of immediate action Upton wanted.

Dr. Ivan Kong, deputy associate U.S. attorney general, similarly hedged. "Once we concluded it is a potential violation, we would investigate it," he said.

Klink asked Kong what was the difference between someone selling controlled substances on the streets or in a school yard and those doing so unlicensed over the Internet.

"The difference is investigatory," explained Kong, who said agents need to be retrained, and the agency retooled to handle Web sites that appear and quickly disappear.

In morning testimony from Christine Behrens, who works for WWMT-TV in Kalamazoo, Michigan, Congress heard that "We logged on to www.worldexpressrx.com and got online consultation on behalf of a cat named Tom.

"[One] question asked about past surgeries. The answer typed in was 'neutered December 15, 1988.' We indicated his weight was 15 pounds and his height 6 inches. Tom's ten pills of 100 mg of the anti-impotence pill Viagra were shipped after $167 was charged to a family credit card," Behrens said.

The testimony wrapped up with representatives from the American Medical
Association and two online drugstores the subcommittee deemed as reputable.

William Razzouk, chief executive of Internet pharmacy PlanetRx.com, called for a national summit of online pharmacies and technology firms to boost enforcement of existing state and federal laws on safe pharmacy practices.

Razzouk suggested the summit, which his company would host in the next 90 days, may produce an industry watchdog system that would use experts and
technology to report improper pharmacy practices to regulators. By pushing self-regulation, he also tried to head off new laws on Internet drugstores.

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